Kornimate/medical-research-clean huggingface dataset:
a phase ii clinical trial of artificial intelligence-assisted one-stop radiotherapy for breast cancer after breast-conserving surgery

Conditions: Breast Cancer Invasive

Summary: background: breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. traditional radiotherapy is complex and time-consuming, affecting patient experience. to streamline this, an ai-assisted all-in-one (aio) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. preliminary results are promising, with significant time savings and high pass rates in initial assessments. further exploration is needed to confirm the accuracy, effectiveness, and safety of aio radiotherapy. primary objective: to conduct a prospective phase ii clinical trial to determine the feasibility (including efficacy and safety) of aio radiotherapy, and to provide a basis for establishing standard operating procedures. secondary objectives: to assess the impact of aio radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. to investigate the incidence and contributing factors of cardiac damage after aio radiotherapy.


Eligibility criteria:
inclusion criteria: * 1. female patients aged 18-70 years. 2. ecog performance status of 0-2. 3. newly diagnosed invasive breast cancer, underwent breast-conserving surgery plus axillary lymph node dissection, with positive axillary lymph nodes (ypn+) and negative surgical margins. 4. no distant metastasis. 5. capable of tolerating radiotherapy. 6. for er/pr-positive patients, willing to receive anticipated 5 years of endocrine therapy. 7. for her2-positive patients, willing to receive anticipated 1 year of anti-her2 targeted therapy. 8. for patients requiring neoadjuvant/adjuvant chemotherapy, must have completed chemotherapy. 9. left ventricular ejection fraction (lvef) measured by echocardiography is 50%. 10. must undergo adjuvant imrt (intensity-modulated radiation therapy). 11. capable of tolerating lying still on the treatment accelerator bed for 30 minutes to complete all-in-one radiotherapy. 12. have follow-up conditions and are willing to adhere to follow-up. 13. signed an informed consent form. exclusion criteria: * 1. synchronous bilateral breast cancer; sentinel lymph node biopsy of the axilla was performed without axillary lymph node dissection. 2. stage i breast reconstruction surgery or expander implantation surgery on the affected side chest wall. 3. the purpose of radiotherapy is palliative. 4. myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina. 5. history of chest wall or supraclavicular radiotherapy in the past; past or concurrent second primary malignant tumors (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, and carcinoma in situ of the cervix). 6. all-in-one one-stop radiotherapy has not been completed.
effect of oocyte denudation time and intracytoplasmic sperm injection time on embryo quality

Conditions: Fertility Disorders

Summary: an observational analytic retrospective study was conduct using cross-sectional study. the subject were oocytes from in-vitro fertilization procedures using the icsi method at the assisted reproductive technology clinic in a private hospital in bandung for the period 2017 - 2019. three variables were oocyte denudation time, icsi time and embryo quality collected from samples that met the research criteria.

this study analyses the different oocyte denudation time after icsi on all embryos generated during ivf procedures between 1 januaryr 2017 and 31 december 2019. all oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.

Eligibility criteria:
inclusion criteria: * oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection exclusion criteria: * oocytes from patients \>40 years old * oocytes from primary infertility \>5 years * endometriosis * polycystic ovarian syndrome

Keywords: infertility assisted reproductive technology embryo quality oocyte denudation intracytoplasmic sperm injection
impact of acute cerebral diseases on the autonomous nervous system: progression and correlation to therapy and outcome

Conditions: Pupillary Function, Abnormal; Cerebral Aneurysm

Summary: the pupilometer determines the alteration of the pupil diameter after a defined light stimulus. in this study data is collected from pupilometer measurements of patients with an acute cerebral disease. the measurements take place during daily neurological routine examinations. the values are compared to outcomes resulting from pupilometer measurements done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without symptoms). the study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.

the pupilometer determines the alteration of the pupil diameter after a defined light stimulus providing information of the autonomic nerve system. the result collecting from pupillometry is objective and more precise than the subjective-visual evaluation of the pupil and its reactivity. in this observational study data is collected from pupilometer measurements of patients with an acute cerebral disease. the measurements take place during neurological routine examinations. the first measurement is done during the initial diagnosing examination, followed by daily measurements and ending with measurements after 3 and 6 month upon hospital discharge. the values are compared to standard values resulting from pupilometer measurements done on patients having non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). the study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.

Eligibility criteria:
inclusion criteria: * male or female patient, age ≥ 18 years * signed consent * treatment group: * patient with acute, cerebral disease verified by ct, mri or spinal tap * control group * patient with non-acute cerebral disease like a new diagnosed aneurysm without symptoms exclusion criteria: * female or male patient aged \< 18 years * absent of signed consent * persons who have a dependent or working relationship with the sponsor or investigator * persons who are sheltered in an institution by juridical or governmental order * concurrent participation in an other clinical study

Keywords: pupillometry autonomous nerve system
data analysis to evaluate which specific gait measures are associated with risk of injurious falls evaluating gait measures associated with the risk of injurious falls through data analysis

Conditions: Women; Age ≥45; After Menopause or Without Intention of Pregnancy

Summary: the goal of this study is to understand if specific gait and activity measures can help predict injurious falls in older women. the main questions it aims to answer are: can combining daily gait (dlg) and daily physical activity (dlpa) measures more accurately predict the risk of injurious falls? how effective is wearable technology and machine learning in analyzing these activity measures for fall prediction? researchers will analyze data from the women's health study (whs), using wearable technology to track daily walking patterns and physical activity, and apply machine learning to assess the likelihood of harmful falls.


Eligibility criteria:
inclusion criteria: * after menopause or without intention of pregnancy exclusion criteria: * history of chd, cerebrovascular disease, cancer (except non-melanoma skin cancer), or other serious illness; * history of serious side effects to study treatments; * taking aspirin, drugs containing aspirin, or non-steroidal anti-inflammatory drugs \&gt; once a week, or ready to give up the use of these drugs; * taking anticoagulants or corticosteroids; * taking vitamin a, e or ß-carotene supplements \&gt; once a week.

Keywords: gait risk of injurious falls gait measures
the impact of implementing a universal newborn screening for critical congenital heart disease

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.


Eligibility criteria:
inclusion criteria: 1. documentation of informed consent and authorization. 2. full term and late preterm newborns (ega 35-44 weeks) 3. on room air 4. neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth 5. parents agree to follow-up contact post discharge exclusion criteria: 1. on supplemental oxygen 2. admitted to the neonatal intensive care unit 3. parents do not agree to follow-up 4. greater than 30 days of age
impact of a hospital physical therapy program on chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the chronic obstructive pulmonary disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. the objective of this study is to verify if a ground walking program applied to hospitalized exacerbated copd patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "body-mass index, airway obstruction, dyspnea, exercise capacity index" (bode index). an evaluators-blinded randomized controlled study will be conducted in "hospital escola municipal de são carlos" where forty patients will be recruited to participate. the volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. it will be evaluated, in the start and at the end of the program, the health related and general quality of life and the barthel index. daily, the patient will be submitted to the six minute walk test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its bode index. all patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. all the collected data will be expressed in means and standard deviations or medians and range when appropriated. it will be chosen appropriated tests to compare and correlate them.


Eligibility criteria:
inclusion criteria: * copd patients (fev1/fvc \ 30% and \< 80%) * hospitalized for exacerbation of copd exclusion criteria: * conditions that could restrict walking * skeletal-muscle and joint disturbs * extreme obesity (bmi \> 35kg/m²) * heart failure (new york heart association class iii and iv) * uncontrolled infection (fever \> 38ºc and leukocytosis \> 10000 cels/dl) * need of invasive mechanical ventilation after the beginning of the program * previous diagnosis of: * stroke * epilepsy * coagulation disorders (inr \> 1,5 or platelets \< 50.000/m³) * psychiatric disorders or severe agitation * cardiac or respiratory instability * oxygen therapy \> 3l/min at rest * respiratory rate \> 30 breaths/min at rest * tachycardia and bradycardia * vasoactive drugs need

Keywords: chronic obstructive pulmonary disease walking hospital exercise tolerance physical therapy
a study of fuzeon (enfuvirtide) with an integrase inhibitor plus optimized background in treatment-experienced hiv-1 infected patients

Conditions: HIV Infections

Summary: this 2-arm study evaluated the efficacy and safety of fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (avr) in hiv-1 infected patients naive to fuzeon and an integrase inhibitor. in the first cohort phase of the study (phase i), eligible patients received fuzeon 90 mg subcutaneously (sc) twice daily until confirmation of response (min/max = 8/16 weeks). in phase ii, the randomised comparator phase of the study, responders were randomized to receive fuzeon either 90 mg sc twice a day or 180 mg sc once a day for a further 16 weeks. non-responders and virological failures were terminated from the study. the anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age * hiv-1 infection * triple class treatment-experienced, fuzeon- and integrase-inhibitor naive * gss \>= 3 ; nucleosides excluded exclusion criteria: * adverse clinical or laboratory experience \>actg grade 4 * untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen * malignancy requiring chemotherapy or radiotherapy

Keywords: treatment experienced
blood pressure reduction induced by cpap in sleep apnea patients at high cardiovascular risk : optisas 2 study

Conditions: Sleep Apnea Syndromes; High Cardiovascular Risk

Summary: targeted population: sleep apnea patients at high cardiovascular risk newly treated by cpap hypothesis: improvement in blood pressure after 6 months of cpap treatment might be greater in the telemonitoring arm compared to usual cpap care. main goal: to compare 6-months blood pressure reduction when sleep apnea patients at high cardiovascular risk are randomly allocated to usual cpap care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

study procedures: the telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, cpap compliance, side effects and residual events. secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. automatic algorithms have been built-up for early adjustment of cpap treatment in case of side effects, leaks and persistent residual events. an interim analysis will be performed when 300 patients will be included.

Eligibility criteria:
inclusion criteria: * age between 18 to 78 years * men and women * ahi \> 30 / hour * patient with high cardiovascular score (\>5% defined by european score) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease) * patient affiliated to the national health insurance * willingness to use a telemonitoring system exclusion criteria: * central sleep apnea syndrome * previous cpap treatment with respiratory support for sleep respiratory trouble * cardiac failure with left ventricular ejection fraction lesser than 40% * hypercapnic chronic respiratory failure (daytime paco2 \> 50 mmhg) * terminal disease

Keywords: obstructive sleep apnea syndrome apnea sleep apnea telemedicine cpap compliance
evaluation of ecallantide for the acute treatment of angiotensin converting enzyme inhibitor induced angioedema

Conditions: Angioedema

Summary: the investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. a rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. in addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.


Eligibility criteria:
inclusion criteria: 1. males and females of any race or ethnicity 18 or older. the locations of the study will permit all racial and ethnic distribution in the study 2. must currently be on an ace inhibitor 3. presenting with ace induced angioedema within 12 hours after onset. this is to be documented in the source document and crf 4. all females of childbearing age must have a negative pregnancy test prior to administration of the study drug. exclusion criteria: 1. participation in another investigational study within 30 days prior to enrollment 2. patients who improve on conventional (standard of care) therapy 3. patients previously treated with ecallantide 4. hypersensitivity to ecallantide 5. pregnancy or breast feeding 6. other definable causes of angioedema (i.e., hereditary or acquired angioedema) 7. patients receiving c-1 inhibitor as prophylaxis 8. treatment requiring tranexamic acid, and epsilon-aminocaproic acid 9. receiving fresh frozen plasma within 3 days prior to enrollment

Keywords: acute angiotensin converting enzyme inhibitor angioedema
a research study looking at how faster aspart injected in double concentration works in the body of people with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: this study is looking at how five different formulations of faster aspart 200 u/ml reach and stay in the blood after injection. the purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 u/ml (marketed as fiasp®). the participant will get all five formulations and the reference product. the order in which the participant gets them is decided by chance. the participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. the medicine will be injected under the skin in the stomach. the study will last for about 2 to 21 weeks depending on individual visit schedule. the participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening exclusion criteria: * participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial * blood donation, plasma donation or blood draw, defined as any of the below: in excess of 400 ml within the past 90 days prior to the day of screening or in excess of 50 ml within the past 30 days prior to the day of screening * use of tobacco and nicotine products, defined as any of the below: smoking more than 1 cigarette or the equivalent per day or not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods
validation of capsovision capsocam® sv-3 capsule endoscopy system

Conditions: Intestinal Disease; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease

Summary: to validate an updated version of capsocam® sv-3 endoscopy system brand name capsocam plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate capsocam® sv-2 and sv-3 capsule endoscopy systems.

the purpose of the study is validate the an updated version of the capsocam® sv-3 endoscopy system brand name capsocam plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate capsocam® sv-2 and sv-3 capsule endoscopy systems. the system to be validated consists of an updated version of the capsocam® sv-3 video capsule endoscope, the capsoview® cvv software, the capsoaccess ® capsule data access system (cdas3) and the capsoretrieve® capsule retrieval kit for the collection of the excreted capsocam capsule. the captured capsocam® sv-3 capsule images of the small bowel will be downloaded via the capsoaccess® capsule data access system (cdas3) to a computer and proprietary capsoview® cvv software is used to review capsule images. the capsoview® software displays the video and employs a variety of image-enhancement, video playback, and image analysis features to facilitate physician review of the captured images. the software allows the physician to efficiently annotate individual frames from the video and compile a procedure report, which aids in diagnosis.

Eligibility criteria:
inclusion criteria: * male or female * willing and able to provide written informed consent * completion of pre-study questionnaire * approval of study principal investigator exclusion criteria: * subjects with abdominal pain of unknown origin * difficulty swallowing * known or suspected gastrointestinal disease * diarrhea or constipation * anemia of unknown origin * rectal or other gastrointestinal bleeding * pregnancy

Keywords: intestinal disease inflammatory bowel diseases crohn disease ulcer celiac disease angioectasia polyp
resection of the primary tumor vs no resection in asymptomatic patients with unresectable synchronous liver metastases from sinen

Conditions: Small Intestinal Neuroendocrine Tumor

Summary: small intestinal neuroendocrine tumors (sinets) incidence is rising. most of sinets primaries are localized in jejunum/ileum. at the diagnosis, 50-70% of them present either lymph node (ln) and/or liver metastases (lm). it is admitted that almost 30% of the patients present or will present primary complications. primary complications include endoluminal obstruction and/or ln-fibrotic mesenteritis with occlusive symptoms, and less frequently haemorrhage and/or intestinal ischemia.however, it is not clear weather this affects patient with or without multiple liver metastases (lm). in this regard, many centres propose to perform primary resection even in patients presenting unresectable lm. thus, systemic reviews suggest a possible benefit of the primary midgut sinets resection even in patients with unresectable lm, there is no prospective randomized trial showing the benefit of primary resection in such patients especially those who are totally asymptomatic. indeed, all retrospective published series have several limitations and the results should be therefore considered with caution. theoretical impact of "preventive" resection of midgut primaries in patients with unresectable lm and totally free of occlusive symptoms is controversial. firstly, it is to avoid primary mechanical complications, and secondly to allow targeting therapeutics to the liver compartment. in this regard, in patients with synchronous unresectable lm from sinens, enets, ukinets, nanets guidelines propose, in "a case-by-case" selective approach, the resection of the primary, while nccn guidelines advocate to do not propose primary resection in such patient if they are free of symptoms with low tumor burden.


Eligibility criteria:
inclusion criteria: * 18 years old * patient with si-net and liver metastases considered as non-resectable * primary-related "asymptomatic" patient at diagnosis * diagnosed during the past 6 months * no symptoms in relation with the primary or with mesenteric lesions * symptoms related to carcinoid syndrome allowed exclusion criteria: * none

Keywords: small intestine neuroendocrine tumor palliative surgery